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To assess the efficacy, safety, and tolerability of intramuscular ziprasidone in the treatment of the acute exacerbation of non-organic psychosis of any etiology, including schizophrenia, acute mania, delusional disorder and others.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ziprasidone | Drug | Intramuscular ziprasidone 10 or 20 mg at the investigator's discretion for 1 to 3 days followed by oral ziprasidone capsules 40 to 80 mg twice daily at the investigator's discretion to complete 7 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Positive and Negative Syndrome Scale (PANSS) excitation items scores | Days 1-3 (end of intramuscular dosing) |
| Measure | Description | Time Frame |
|---|---|---|
| Electrocardiogram at Visits 1 and 5 | Visits 1 (Screening) and 5 (Day 7) | |
| Adverse events at Visits 2, 3, 4, and 5 | Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Fortaleza | Ceará | 60175-270 | Brazil | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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|
| Change from baseline in Patient Preference Scale (PPS) scores at Visits 3 and 5 |
| Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4) and 5 (Day 7) |
| Laboratory tests at Visits 1 and 5 | Visits 1 (Screening) and 5 (Day 7) |
| Movement disorder rating scale scores (Barnes Akathisia Scale and Extrapyramidal Symptoms Rating Scale) at Visits 2, 3, 4, and 5 | Visits 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) |
| Change from baseline in PANSS excitation items scores at Visits 3, 4, and 5 | Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) |
| Blood pressure and pulse at Visits 1, 2, and 5 | Visits 1 (Screening), 2 (Day 1), and 5 (Day 7) |
| Change from baseline in Clinical Global Impression-Severity (CGI-S) scores at Visits 3, 4, and 5 | Visits 1 (Screening), 2 (Day 1), 3 (Day 1, 2, 3, or 4), 4 (Day 5), and 5 (Day 7) |
| Salvador |
| Estado de Bahia |
| 41180-000 |
| Brazil |
| Pfizer Investigational Site | Belo Horizonte | Minas Gerais | 30150-270 | Brazil |
| Pfizer Investigational Site | Curitiba | Paraná | Brazil |
| Pfizer Investigational Site | Rio de Janeiro | Rio de Janeiro | Brazil |
| Pfizer Investigational Site | São Gonçalo | Rio de Janeiro | Brazil |
| Pfizer Investigational Site | Jardim Santa Monica SN | Salvador - BA | 40340-720 | Brazil |
| Pfizer Investigational Site | São Paulo | São Paulo | Brazil |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D000087122 | Mania |
| D012563 | Schizophrenia, Paranoid |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C092292 | ziprasidone |
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